MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CATRX ASPIRATION CATHETER; QEX, QEW

Catalog Number CATRXKIT

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2023

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure using an indigo system catrx aspiration catheter (catrx).During the procedure, it was reported when the physician was retracting the catrx out from the patient, the catrx had broken.Therefore, the physician used a snare device to remove the broken portion of the catrx.No additional information regarding the completion of the procedure was provided.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned catrx confirmed a fracture on the distal catheter shaft.If the device is retracted against resistance, damage such as this may occur.Further evaluation revealed a kink and stretch near the fracture, and the guidewire lumen was damaged on its proximal end.This damage also likely occurred during retraction against resistance.Based on the reported event, the root cause of resistance could not be determined.Further evaluation revealed additional bends along the catheter shaft, and a kink on the distal fractured segment.This distal kink likely occurred during snaring of the fractured segment during the procedure.The additional kinks were likely incidental to the complaint and may have occurred during packaging for return to penumbra.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report:3005168196-2023-00239.Section g.Box 3.Report source.Please note that this complaint was submitted to the fda by the user facility with the following reference number: (b)(4).

• Brand Name: INDIGO SYSTEM CATRX ASPIRATION CATHETER
• Type of Device: QEX, QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 16968502
• MDR Text Key: 315773109
• Report Number: 3005168196-2023-00239
• Device Sequence Number: 1
• Product Code: QEX
• UDI-Device Identifier: 00814548017556
• UDI-Public: 814548017556
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F00004785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 04/25/2023
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: 06/06/2023; 01/14/2005
• Supplement Dates FDA Received: 06/28/2023; 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Female